Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

NCT04229264

Last updated date
Study Location
IAMSPE - Sao Paulo Public Servants Hospital
São Paulo, , 04039000, Brazil
Contact
+5501144688183

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Critical Limb Ischemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Written informed consent.

- Age>18 years old.

- Negative serum pregnancy test (in women of childbearing only).

- Patients submitted to endovascular procedures below-the-knee by not exclusively.

- Patient understands and is willing and able to comply with the study instructions and follow-up visit.

- More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).

- Tissue loss (Rutherford 5).

- One or more patent vessel of pedal arch.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- TASC II D femoral and/or popliteal occlusion.


- Life expectancy less than 1 year.


- Allergy or contraindication to apixaban treatment.


- Allergy or contraindication to dual antiplatelet treatment.


- Creatinine clearance less than 30mL/min.


- Planned major amputation before procedure.


- Hybrid procedure (open and endovascular).


- Use of fibrinolytic in the past 10 days.


- Known HIV infection.


- Liver disease (acute or chronic hepatitis and cirrhosis).


- Drug addiction or alcohol abuse 12 months before the randomization.


- Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein
(ketoconazole, Iitraconazole, ritonavir).


- Platelets count inferior to 100x109/L.


- INR more than 1.5.


- History or condition with high risk of bleeding: Eg. Trauma within 30 days before
randomization, gastrointestinal bleeding 6 month before the randomization,
intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation,
cerebral aneurysm and hypertension without control.

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Critical Limb IschemiaEfficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.
NCT04229264
  1. São Paulo,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.
Official Title  ICMJE Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb
Brief Summary This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.
Detailed Description This study is a multicentre, parallel-group, prospective, randomized open-label, blinded-endpoint adjudication, proof-of-concept, and exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once-daily for 12 months. In the control group, aspirin 100 mg once-daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE
  • Drug: Apixaban
    Oral Apixaban 2.5 mg twice daily for one year
    Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months
  • Drug: ASA
    Acetil Salicilic Acid 100mg once daily for one year
  • Drug: Clopidogrel 75mg
    Clopidogrel 75mg once daily for 3 months
    Other Name: Doppler Ultrasound Follow-up 1, 3, 6 and 12 months
Study Arms  ICMJE
  • Active Comparator: Control group
    Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
    Interventions:
    • Drug: ASA
    • Drug: Clopidogrel 75mg
  • Experimental: Apixaban group
    Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
    Interventions:
    • Drug: Apixaban
    • Drug: ASA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2, 2022
Estimated Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent.
  • Age>18 years old.
  • Negative serum pregnancy test (in women of childbearing only).
  • Patients submitted to endovascular procedures below-the-knee by not exclusively.
  • Patient understands and is willing and able to comply with the study instructions and follow-up visit.
  • More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).
  • Tissue loss (Rutherford 5).
  • One or more patent vessel of pedal arch.

Exclusion Criteria:

  • TASC II D femoral and/or popliteal occlusion.
  • Life expectancy less than 1 year.
  • Allergy or contraindication to apixaban treatment.
  • Allergy or contraindication to dual antiplatelet treatment.
  • Creatinine clearance less than 30mL/min.
  • Planned major amputation before procedure.
  • Hybrid procedure (open and endovascular).
  • Use of fibrinolytic in the past 10 days.
  • Known HIV infection.
  • Liver disease (acute or chronic hepatitis and cirrhosis).
  • Drug addiction or alcohol abuse 12 months before the randomization.
  • Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein (ketoconazole, Iitraconazole, ritonavir).
  • Platelets count inferior to 100x109/L.
  • INR more than 1.5.
  • History or condition with high risk of bleeding: Eg. Trauma within 30 days before randomization, gastrointestinal bleeding 6 month before the randomization, intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation, cerebral aneurysm and hypertension without control.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leandro Agati, PhD+5501144688183[email protected]
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04229264
Other Study ID Numbers  ICMJE AGRIPPA/EMRISTA 2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Science Valley Research Institute
Study Sponsor  ICMJE Science Valley Research Institute
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE Not Provided
PRS Account Science Valley Research Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP